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Anticipate the outcomes and implications of 2013’s key FDA approval decisions.


Although 2012 witnessed the FDA approve 39 new drugs and biological entities, drugs approved for the treatment of disorders of the central nervous system (CNS) accounted for just two of these successful candidates – Aubagio (teriflunomide) gained approval for multiple sclerosis (MS) and Fycompa (perampanel) for epilepsy.


In 2013 however, we anticipate a far more productive outlook for the CNS sector. Several promising candidates for psychiatric and neurological indications were filed for approval in the US in 2012, with at least six expected to demonstrate significant clinical benefit to win FDA approval over the next 12 months.